Role at a glance
- Job function
-
Engineering & R&D Biotechnology & Pharmaceutical R&D
- Salary
- $213.4K – $396.2K/yr
- Location
- South San Francisco, United States
- Work arrangement
- On-site
- Employment
- Full-time
- Experience
- 2+ years of clinical, translational, or basic research experience
- Education
- M.D. with Board Certification or eligibility
Spotted an issue?
We’ll check it against the original posting.
Role Summary
The Early Clinical Development OMNI group at Genentech advances early clinical development programs in immunology from First-in-Human studies through Proof-of-Concept and initial pivotal decisions. This role supports the development of novel molecular entities by integrating clinical, scientific, regulatory, and cross-functional perspectives.
What You'll Do
- Author clinical protocols and design early-phase Phase I/II studies.
- Provide medical oversight, safety monitoring, and clinical expertise across active trials.
- Represent Clinical Science on Clinical Science Teams and Protocol Execution Teams.
- Author clinical sections for INDs, IBs, and health authority briefing materials.
- Collaborate with research groups, external Key Opinion Leaders, and scientific advisory boards to inform disease area strategies and...
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
M.D. with Board Certification or eligibility in Gastroenterology, Pulmonary, Rheumatology, Nephrology, or a related specialty; 2+ years of clinical, translational, or basic research experience with a demonstrated focus on immunology or inflammation; thorough understanding of early clinical drug development principles, trial methodology, GCP/ICH guidelines, and clinical data interpretation; effective communication and collaboration skills.
Required
- M.D. with Board Certification or eligibility in Gastroenterology, Pulmonary, Rheumatology, Nephrology, or a related specialty
- 2+ years of clinical, translational, or basic research experience
- Demonstrated focus on immunology or inflammation
- Understanding of early clinical drug development principles (Phases I–II)
- Understanding of trial methodology and GCP/ICH guidelines
- Clinical data interpretation
- Ability to synthesize complex biomarker and safety data
- Effective communication skills
Preferred
- M.D./Ph.D.
Original job description
Content provided by the employer
Original job description
Content provided by the employer
We advance science so that we all have more time with the people we love.
The Early Clinical Development (ECD) OMNI group at Genentech drives innovation across a broad portfolio of immunology indications, advancing breakthrough science from First-in-Human studies through Proof-of-Concept and initial pivotal decisions. Driven by gRED’s mission to make fundamental scientific discoveries and help develop them into best-in-class therapeutics that provide unique benefits to patients, our team translates complex biology into transformative therapies.
The Opportunity:
Drive Clinical Trial Design: Author clinical protocols and design early-phase (Phase I/II) studies to establish biologic and clinical proof-of-concept for novel molecular entities (NMEs).
Serve as Medical Monitor: Provide medical oversight, safety monitoring, and clinical expertise across active trials while collaborating with trial sites, investigators, and CROs.
Lead Cross-Functional Strategy: Represent Clinical Science on multi-disciplinary Clinical Science Teams (CST) and Protocol Execution Teams (PET), integrating insights across biomarkers, safety, regulatory, and commercial functions.
Guide Regulatory & Asset Strategy: Author clinical sections for INDs, IBs, and health authority briefing materials, supporting direct interactions with global regulatory bodies (FDA, EMA).
Engage Global Scientific Leaders: Collaborate with internal research groups, external Key Opinion Leaders (KOLs), and scientific advisory boards to refine disease area strategies and inform portfolio decisions.
Who You Are:
Clinical Expertise: M.D. with Board Certification or eligibility in Gastroenterology, Pulmonary, Rheumatology, Nephrology, or a related specialty (M.D./Ph.D. preferred).
Research Track Record: 2+ years of clinical, translational, or basic research experience within academia or the biopharmaceutical industry, with a demonstrated focus on immunology or inflammation.
Development Acumen: Thorough understanding of early clinical drug development principles (Phases I–II), trial methodology, GCP/ICH guidelines, and sophisticated clinical data interpretation.
Strategic & Collaborative Mindset: Adept at synthesizing complex biomarker and safety data to shape asset strategy and influence decisions across cross-functional matrix teams.
Scientific Communicator: Highly effective communicator capable of building strong collaborative networks with academic investigators, regulatory bodies, and internal research partners.
Relocation benefits are available for this posting.
Onsite presence, on our South San Francisco campus, is expected for at least 3 days a week.
The expected salary range for this position based on the primary location of South San Francisco, California is $213,400 - $396,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
#ECD
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
About the company
Genentech
Large Enterprise
Genentech, a member of the Roche Group, is a biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines for patients with serious medical conditions. Founded in 1976, Genentech has played a pioneering role in the biotech industry, particularly in the development of targeted therapies for cancer and other diseases. The company is committed to advancing science and addressing unmet medical needs through cutting-edge research and collaboration, making it a leader in the field of biotechnology. With a strong emphasis on sustainability and corporate responsibility, Genentech is dedicated to improving patient outcomes and enhancing healthcare globally.